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A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fed Conditions

NCT00864890 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-08-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fed conditions.

Conditions

  • Healthy

Interventions

DRUG

Citalopram HBr 40 mg tablets, single dose

A: Experimental Subjects received Purepac formulated products under fed conditions

DRUG

CelexaTM 40 mg tablets, single dose

B: Active comparator Subjects received Forest Labs formulated products under fed conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, M.D. · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2003-07-31
Completion
2003-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00864890 on ClinicalTrials.gov